Collection of Digital Parameters From Parts of the Neurological Examination Using an Eye Tracker (NEX-Eye)

University of Kiel

Status: Not yet enrolling

Conditions: Geriatric; Progressive Supranuclear Palsy(PSP); Parkinsons Disease (PD); Neurological Diseases or Conditions

Study type: Observational

Funder types: Other

Identifiers

NCT07141719

D 481/25

Details and patient eligibility

About

The neurological examination (NE) is a cornerstone of clinical neurology, with ocular motor assessment being a key component. Technology offers an opportunity to augment and standardize parts of the NE. Eye-tracking systems provide objective quantitative data on eye movements by continuously tracking the eye over time. This data can be used to derive parameters like saccadic latency, gaze velocity, and fixation stability with a precision that is impossible to achieve through human observation by neurologists. The integration of such technology could enhance the traditional NE.

Before such technology can be widely adopted, its feasibility and acceptability in a clinical population must be established. The primary purpose of this study is to assess the usability of a novel eye-tracking system from the patient's perspective when used in a clinical settings. A secondary purpose is to determine if quantitative data from the eye-tracker correlate with the findings of the traditional clinical neurological examination and to explore whether eye-tracking can provide additional, complementary information not typically captured by standard clinical assessment.

To achieve these aims, the study will assess several outcome measures. The primary outcome measure is the Usability of the Eye-Tracking System, which will be measured using the System Usability Scale (SUS).

Beyond the primary objectives, this study will investigate two secondary objectives.

The first involves assessing the relationship between quantitative eye-tracking parameters and clinical ocular motor assessment. Specifically, the investigators will analyze objective, numerical data obtained from eye-tracking systems and the clinician's subjectively graded assessment of ocular movements derived from the standard neurological examination.

The second is the exploratory analysis of novel eye-tracking biomarkers. This involves quantifying and analyzing eye-tracking parameters not typically assessed during a routine NE. For example, the dynamics of the pupillary light reflex or the frequency of microsaccades. The aim is to identify potential digital biomarkers that could provide additional objective insights into ocular motor function and neurological status.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 years of age.
• Diagnosed or treated for a neurological disease.
• Hospitalized or outpatient of the Department of Neurology, UKSH Campus Kiel.
• Ability of the person to understand oral study information and study information sheet, and willingness to provide a signed and dated informed consent form.

Exclusion criteria

• Being under legal guardianship
• Impaired decision-making capacity, or temporal or spatial disorientation which may be revealed within ordinary conversation or by a confirmed diagnosis of dementia. In case of doubt, the Montreal Cognitive Assessment (MoCA, pass cutoff score > 18 16) will be administered.

Trial design

600 participants in 1 patient group

Persons with neurological conditions

Description:

Patients admitted to the wards and the outpatient clinics of the Department of Neurology, Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel